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A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway
Trial Status: closed to accrual
This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability,
PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849
(adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the
KRAS-MAPK pathways.
Inclusion Criteria
Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test:
MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
Unresectable or metastatic disease
No available treatment with curative intent; standard treatment is not available or patient declines
Presence of tumor lesions to be evaluated per RECIST 1.1:
Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease
Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation at baseline and on-study unless Sponsor-confirmed as medically unsafe or infeasible.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function
Exclusion Criteria
Active brain metastases or carcinomatous meningitis
Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only)
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
Major surgery within 4 weeks of first dose of study treatment
History of pneumonitis or interstitial lung disease
Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors
Cardiac abnormalities
History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications
Additional locations may be listed on ClinicalTrials.gov for NCT05578092.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Status: Active
Name Not Available
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
Texas
Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and
regimen. Once safety experience and PK data are available for the monotherapy regimen,
dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will
include a separate preliminary food effect assessments on MRTX0902 PK in combination with
adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may
be implemented to ensure collection of sufficient safety and PK information, and early
evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2,
separate cohorts of patients by histological diagnosis and/or baseline characteristics
will be evaluated for the clinical activity and efficacy of MRTX0902 in combination with
